Philips Electronics North America
Andover, MA, United States
In this role, you have the opportunity to
Manage the complaint investigation process and worldwide MDR/Adverse event reporting. You will work with other teams in a collaborative environment to complete the end-to-end complaints process.
You are responsible for
Evaluate, investigate, track and complete complaints through effective and established complaint handling processes.
Ensure accurate documentation of evaluation and investigation results with the assigned complaint records.
Participate and collaborate objectively with team members to achieve consistent process while identifying process improvements to drive efficiency and compliance.
Collaborate with a variety of diverse persons such as Engineers, Scientists, Clinical Specialists, Field Service Engineers, Professional Customers and Manufacturing personnel to facilitate the complaint investigation process globally.
Review each complaint for and determine eligibility for adverse event reporting to worldwide regulatory agencies.
Prepare and submit adverse event reports to appropriate regulatory agencies.
Assist in trending of complaints and collaborate with the appropriate groups to ensure accuracy of data.
Support reviews and audits as required.
Other projects assigned.
You are a part of
The Patient Monitoring Post Market Surveillance Team is headquartered out of Andover, MA. We welcome you to join Philips HealthTech as a Complaint Investigator supporting Patient Monitoring and Medical Consumable Suppliers. The Quality and Regulatory team enables meaningful innovation for our customers by partnering with and guiding the business to achieve world-class quality and regulatory compliance in a rapidly changing environment, while creating a great workplace for our people to realize their career aspirations.
To succeed in this role, you should have the following skills and experience
5 years post-market complaints experience in a medically regulated industry.
Bachelor’s degree in engineering, clinical sciences, related sciences, or relevant related experience
Proficiency using office tools such as Microsoft Office Suite and various other computer software applications.
Working knowledge of appropriate global medical device regulations, requirements, and standards such as ISO 13485 and ISO9001, and FDA QSR. Medical Device and or other regulated industry (Pharma, IVD,).
An organized, analytical thinker with exceptional attention to detail.
An excellent communicator, both written and verbal for coordinating with colleagues and regulatory authorities worldwide.
Able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives.
Must be able to work under pressure to meet regulatory reporting time frames and company requirements.
Experience in TrackWise or similar system is preferable.
In return, we offer you
At Philips, we strive to make the world healthier and more sustainable through innovation, and our goal is to improve the lives of 3 billion people a year by 2025. This position offers the opportunity to influence regulatory compliance worldwide and directly improve the customer and patient experience. We offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/Philips
Disease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
Philips Electronics North America
Website : http://www.usa.philips.com
Since the introduction of the first Philips light bulb more than 120 years ago, innovation and a people-centric approach have always been at the core of our company.